# FDA recall Z-0959-2025

> **A L I Technologies Ltd** · Class II · device recall initiated 2024-12-02.

## Product

Change Healthcare Cardiology Hemodynamics software

## Reason for recall

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

## Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.

## Key facts

- **Recall number:** Z-0959-2025
- **Recalling firm:** A L I Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-02
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burnaby, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2025

## Citation

> AI Analytics. FDA recall Z-0959-2025. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0959-2025. Source: US FDA. Licensed CC0.

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